Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification, 56852-56854 [2018-24790]
Download as PDF
<![CDATA[
56852
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
et al., ‘‘Prescribers’ Knowledge and Skills
for Interpreting Research Results: A
Systematic Review,’’ Journal of
Continuing Education in the Health
Professions, 37(2):129–136, 2017.
* 15. Tversky, A. and D. Kahneman,’’
Judgment Under Uncertainty: Heuristics
and Biases,’’ Science, 185(4157):1124–
1131, 1974.
* 16. Gehlbach, H. and S. Barge, ‘‘Anchoring
and Adjusting in Questionnaire
Responses,’’ Basic and Applied Social
Psychology, 34(5):417–433, 2012.
* 17. Epley, N. and T. Gilovich, ‘‘The
Anchoring-and-Adjustment Heuristic:
Why the Adjustments are Insufficient,’’
Psychological Science, 17(4):311–318,
2006.
* 18. Ho¨hne, J.K. and D. Krebs, ‘‘Scale
Direction Effects in Agree/Disagree and
Item-Specific Questions: A Comparison
of Question Formats,’’ International
Journal of Social Research Methodology,
21(1):91–103, 2017.
* 19. Saris, W.E., M. Revilla, J.A. Krosnick, et
al., ‘‘Comparing Questions with Agree/
Disagree Response Options to Questions
with Item-Specific Response Options’’
Survey Research Methods, 4:61–79,
2010.
* 20. Krosnick, J.A. and S. Presser, ‘‘Question
and Questionnaire Design,’’ In:
Handbook of Survey Research (pp. 263–
314). Bingley, United Kingdom: Emerald
Group Publishing Limited, 2010.
21. Converse, J.M. and S. Presser, Survey
Questions: Handcrafting the
Standardized Questionnaire, (No. 63).
Thousand Oaks, CA: SAGE Publications,
1986.
22. DeVellis, R.F., Scale Development:
Theory and Applications, (Vol. 26).
Thousand Oaks, CA: SAGE Publications,
2016.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24785 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4206]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Small Business Qualification
and Certification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
SUMMARY:
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on Form FDA 3602
and Form FDA 3602A, which will allow
domestic and foreign applicants to
certify that they qualify as a small
business and pay certain medical device
user fees at reduced rates.
DATES: Submit either electronic or
written comments on the collection of
information by January 14, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 14,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 14, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–4206 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device User Fee Small Business
Qualification and Certification.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
E:\FR\FM\14NON1.SGM
14NON1
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device User Fee Small
Business Qualification and Certification
OMB Control Number 0910–0508—
Extension
Medical device user fees were first
established in 2002 by the Medical
Device User Fee and Modernization Act
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
(MDUFMA) (Pub. L. 107–250). User fees
were renewed in 2007, with the Medical
Device User Fee Amendments to the
FDA Amendments Act (MDUFA II), in
2012 with the Medical Device User Fee
Amendments to the FDA Safety and
Innovation Act (MDUFA III), and in
2017 with the Medical Device User Fee
Amendments to the FDA
Reauthorization Act (MDUFA IV).
MDUFA IV will be in place from
October 1, 2017, until September 30,
2022.
A business that is qualified and
certified as a ‘‘small business’’ is eligible
for a substantial reduction in most of
these user fees. The guidance document
entitled ‘‘Medical Device User Fee
Small Business Qualification and
Certification Guidance for Industry,
Food and Drug Administration Staff and
Foreign Governments’’ describes the
criteria FDA will use to decide whether
an entity is eligible for a reduction in
user fees and the process by which a
business may request certification as a
small business.
An applicant can qualify for a small
business fee discount under MDUFMA
if they reported gross receipts or sales of
no more than $100 million on their
Federal income tax return for the most
recent tax year. If they have any
affiliates, partners, or parent firms, the
applicant must add the gross receipts or
sales of the affiliates, partners, or parent
firms to the applicant’s, and the total
must be no more than $100 million. If
the applicant’s gross receipts or sales are
no more than $30 million, including all
of their affiliates, partners, and parent
firms, they will also qualify for a waiver
of the fee for their first (ever) premarket
application (product development
protocol, biologics licensing
application, or premarket report). An
applicant must pay the full standard fee
unless it provides evidence
demonstrating to FDA that it meets the
small business criteria (Form FDA 3602,
‘‘MDUFA Small Business Certification
Request for a Business Headquartered in
the United States’’). The evidence
required by MDUFMA is a copy of the
most recent Federal income tax return of
the applicant, and any affiliate, partner,
or parent firm. FDA will review these
materials and decide whether an
applicant is a small business within the
meaning of MDUFMA.
MDUFA II provided an alternative
way for a foreign business to qualify as
a small business eligible to pay a
significantly lower fee when a medical
device user fee must be paid (Form FDA
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
56853
3602A, ‘‘MDUFA Foreign Small
Business Certification Request for a
Business Headquartered Outside the
United States’’). Before passage of
MDUFA II, the only way a business
could qualify as a small business was to
submit a Federal (U.S.) income tax
return showing its gross receipts or sales
that did not exceed a statutory
threshold, currently, $100 million. If a
business could not provide a Federal
income tax return, it did not qualify as
a small business and had to pay the
standard (full) fee. Because many
foreign businesses have not, and cannot,
file a Federal (U.S.) income tax return,
this requirement effectively prevented
those businesses from qualifying for the
small business fee rates. Thus, foreign
governments, including the European
Union, objected. In lieu of a Federal
income tax return, the MDUFA II
allowed a foreign business to qualify as
a small business by submitting a
certification from its national taxing
authority, the foreign equivalent of our
Internal Revenue Service. This
certification, referred to as a ‘‘National
Taxing Authority Certification,’’ must:
(1) Be in English; (2) be from the
national taxing authority of the country
in which the business is headquartered;
(3) provide the business’ gross receipts
or sales for the most recent year, in both
the local currency and in U.S. dollars,
and the exchange rate used in
converting local currency to U.S.
dollars; (4) provide the dates during
which the reported receipts or sales
were collected; and (5) bear the official
seal of the national taxing authority.
Forms FDA 3602 and FDA 3602A are
available in the guidance document
entitled ‘‘Medical Device User Fee
Small Business Qualification and
Certification Guidance for Industry,
Food and Drug Administration Staff and
Foreign Governments’’ on the internet
at: https://www.fda.gov/ucm/groups/
fdagov-public/@fdagov-meddev-gen/
documents/document/ucm456779.pdf.
The estimated burden is based on the
number of applications received in the
last 3 years and includes time required
to collect the required information.
Based on our experience with Form
FDA 3602, FDA believes it will take
each respondent 1 hour to complete the
form. Based on our experience with
Form FDA 3602A, FDA also believes
that it will take each respondent 1 hour
to complete.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\14NON1.SGM
14NON1
56854
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form No.
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
FDA 3602—MDUFA Small Business Certification Request
For a Business Headquartered in the United States .......
FDA 3602A—MDUFA Foreign Small Business Certification
Request For a Business Headquartered Outside the
United States ....................................................................
5,000
1
5,000
1
5,000
2,000
1
2,000
1
2,000
Total ..............................................................................
........................
........................
........................
........................
7,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 2,000 hours and a
corresponding increase of 2,000
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24790 Filed 11–13–18; 8:45 am]
recommendations that will facilitate the
universal acceptance of the generated
residue depletion data to fulfill the
national/regional requirements in order
to establish appropriate Maximum
Residue Limits (MRLs) or other safe
limits in honey following the treatment
of honeybees with veterinary drug
products, or to justify withdrawal
periods in honey for registration or
approval purposes, as applicable, when
an MRL already exists.
The announcement of the
guidance is published in the Federal
Register on November 14, 2018.
BILLING CODE 4164–01–P
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Food and Drug Administration
[Docket No. FDA–2016–D–4461]
Electronic Submissions
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Study
Design Recommendations for Residue
Studies in Honey for Establishing
Maximum Residue Levels and
Withdrawal Periods; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry (GFI) #243
entitled ‘‘Studies to Evaluate the
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56). This
guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This VICH guidance document
is intended to provide study design
SUMMARY:
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–4461 for ‘‘Studies to Evaluate
the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56).
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56852-56854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24790]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4206]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device User Fee Small Business Qualification
and Certification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Form FDA 3602 and Form FDA 3602A, which
will allow domestic and foreign applicants to certify that they qualify
as a small business and pay certain medical device user fees at reduced
rates.
DATES: Submit either electronic or written comments on the collection
of information by January 14, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 14, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-4206 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device User Fee Small
Business Qualification and Certification.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the
[[Page 56853]]
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device User Fee Small Business Qualification and Certification
OMB Control Number 0910-0508--Extension
Medical device user fees were first established in 2002 by the
Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-
250). User fees were renewed in 2007, with the Medical Device User Fee
Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the
Medical Device User Fee Amendments to the FDA Safety and Innovation Act
(MDUFA III), and in 2017 with the Medical Device User Fee Amendments to
the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be in place from
October 1, 2017, until September 30, 2022.
A business that is qualified and certified as a ``small business''
is eligible for a substantial reduction in most of these user fees. The
guidance document entitled ``Medical Device User Fee Small Business
Qualification and Certification Guidance for Industry, Food and Drug
Administration Staff and Foreign Governments'' describes the criteria
FDA will use to decide whether an entity is eligible for a reduction in
user fees and the process by which a business may request certification
as a small business.
An applicant can qualify for a small business fee discount under
MDUFMA if they reported gross receipts or sales of no more than $100
million on their Federal income tax return for the most recent tax
year. If they have any affiliates, partners, or parent firms, the
applicant must add the gross receipts or sales of the affiliates,
partners, or parent firms to the applicant's, and the total must be no
more than $100 million. If the applicant's gross receipts or sales are
no more than $30 million, including all of their affiliates, partners,
and parent firms, they will also qualify for a waiver of the fee for
their first (ever) premarket application (product development protocol,
biologics licensing application, or premarket report). An applicant
must pay the full standard fee unless it provides evidence
demonstrating to FDA that it meets the small business criteria (Form
FDA 3602, ``MDUFA Small Business Certification Request for a Business
Headquartered in the United States''). The evidence required by MDUFMA
is a copy of the most recent Federal income tax return of the
applicant, and any affiliate, partner, or parent firm. FDA will review
these materials and decide whether an applicant is a small business
within the meaning of MDUFMA.
MDUFA II provided an alternative way for a foreign business to
qualify as a small business eligible to pay a significantly lower fee
when a medical device user fee must be paid (Form FDA 3602A, ``MDUFA
Foreign Small Business Certification Request for a Business
Headquartered Outside the United States''). Before passage of MDUFA II,
the only way a business could qualify as a small business was to submit
a Federal (U.S.) income tax return showing its gross receipts or sales
that did not exceed a statutory threshold, currently, $100 million. If
a business could not provide a Federal income tax return, it did not
qualify as a small business and had to pay the standard (full) fee.
Because many foreign businesses have not, and cannot, file a Federal
(U.S.) income tax return, this requirement effectively prevented those
businesses from qualifying for the small business fee rates. Thus,
foreign governments, including the European Union, objected. In lieu of
a Federal income tax return, the MDUFA II allowed a foreign business to
qualify as a small business by submitting a certification from its
national taxing authority, the foreign equivalent of our Internal
Revenue Service. This certification, referred to as a ``National Taxing
Authority Certification,'' must: (1) Be in English; (2) be from the
national taxing authority of the country in which the business is
headquartered; (3) provide the business' gross receipts or sales for
the most recent year, in both the local currency and in U.S. dollars,
and the exchange rate used in converting local currency to U.S.
dollars; (4) provide the dates during which the reported receipts or
sales were collected; and (5) bear the official seal of the national
taxing authority.
Forms FDA 3602 and FDA 3602A are available in the guidance document
entitled ``Medical Device User Fee Small Business Qualification and
Certification Guidance for Industry, Food and Drug Administration Staff
and Foreign Governments'' on the internet at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm456779.pdf.
The estimated burden is based on the number of applications
received in the last 3 years and includes time required to collect the
required information. Based on our experience with Form FDA 3602, FDA
believes it will take each respondent 1 hour to complete the form.
Based on our experience with Form FDA 3602A, FDA also believes that it
will take each respondent 1 hour to complete.
FDA estimates the burden of this collection of information as
follows:
[[Page 56854]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
FDA 3602--MDUFA Small Business 5,000 1 5,000 1 5,000
Certification Request For a
Business Headquartered in the
United States..................
FDA 3602A--MDUFA Foreign Small 2,000 1 2,000 1 2,000
Business Certification Request
For a Business Headquartered
Outside the United States......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 7,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall increase of 2,000 hours and a corresponding increase of 2,000
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24790 Filed 11-13-18; 8:45 am]
BILLING CODE 4164-01-P
